FDA Inspection 918357 — Cellestis Inc
The FDA completed an inspection of Cellestis Inc on March 25, 2015 in Santa Clarita, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 25, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Santa Clarita, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 774 | 21 CFR 803.52(e)(4) | Date Received by Manufacturer |